Regulatory requirements Harmonization

In recent years, regulatory authorities and industry associations have undertaken several important initiatives to promote international harmonization of regulatory requirements. These efforts are designed to enhance harmonization and are committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. These efforts are undertaken under the auspices of the International Conference on Harmonization (ICH), which is organized to provide an opportunity for tripartite... 

Globalization of fhe pharmaceufical industry has created the need to harmonize the recommendations for fhe developmenf of new pharmaceuticals as well as the regulatory requirements. To address this need, in 1990, experts from the pharmaceutical industry and regulators from fhe United States, Europe, and Japan joined together to establish the ICFl... 

Tableting process, since being introduced in the early 1840s, has witnessed numerous changes in the form of stringent regulatory requirements for the excipients and product stability. Increasing regulatory pressure on purity, safety, and standardization of the excipients has catalyzed the formation of an international body, the International Pharmaceutical Excipients Council (IPEC) (13). IPEC is a tripartite council with representation from the United States, Europe, and Japan, and has made serious efforts to harmonize requirements for purity and functionality testing of excipients (14).

Global Harmonization Task Force (GHTF), which was formed to harmonize regulatory requirements for the medical device may recommend referring to ISO 10013 for general guidance on the content of a quality manual. 

The FDA is announcing the Agency s policy on the development and use of standards with respect to international harmonization of regulatory requirements and guidelines. Specifically, the policy is intended to address the conditions under which the FDA plans to participate with standards bodies outside of the FDA, domestic or international, in the development of standards applicable to products regulated by the FDA. The policy also covers the conditions under which the FDA intends to use the resultant standards, or other available domestic or international standards, in fulfilling its statutory mandates for safeguarding the public health. 

The purpose of this document is to articulate the FDA s policy on development and use of standards with respect to international harmonization of regulatory requirements and guidelines. As used throughout this document, the term standards includes what are commonly referred to as consensus standards, voluntary standards, and industry standards. Also, the FDA sometimes accepts standards and makes them mandatory regulatory requirements. Although the draft policy focuses on international harmonization and international standards, its principles are applicable as well to domestic standards activities in which the FDA participates. 

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